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ACIPHEX®
rabeprazole sodium tablets
http://www.aciphex.com
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ACIPHEX® (rabeprazole sodium) Delayed-Release Tablets, discovered and developed by Eisai Co. Ltd., is a proton pump inhibitor that reduces the amount of acid in your stomach.
ACIPHEX 20 mg once daily was approved by the United States Food and Drug Administration in 1999 and is indicated in adults (≥18 years of age).
ACIPHEX® SprinkleTM (rabeprazole sodium) Delayed-Release Capsules was approved by the United States Food and Drug Administration in March 2013.
In adults (≥18 years of age), one ACIPHEX 20 mg tablet daily is used for the treatment of daytime and nighttime heartburn and other symptoms associated with acid reflux disease. ACIPHEX is also used for the short-term (4 to 8 weeks) treatment in the healing and symptom relief of damaging (erosive) acid reflux disease (gastroesophageal reflux disease) and to maintain healing of damage (erosion) and relief of heartburn symptoms that happen with acid reflux disease. ACIPHEX has not been studied for treatment lasting longer than 12 months (1 year).
In adolescents (≥12 years of age), one ACIPHEX 20 mg tablet daily is used for the treatment of daytime and nighttime heartburn and other symptoms associated with acid reflux disease.
In children (1 to 11 years of age) ACIPHEX® SprinkleTM is used for the treatment of acid reflux disease for up to 12 weeks.
It is a chronic condition that develops when acid content from the stomach flows back into the esophagus,and is most commonly associated with heartburn.
In the United States, Aciphex is manufactured and marketed by Eisai Inc. and marketed by Janssen Pharmaceuticals, Inc.
Important Safety Information:
- Symptom relief does not rule out other serious stomach conditions.
- Serious allergic reactions may occur. Tell your doctor if you have a rash, face swelling, throat tightness, or difficulty breathing.
- Proton Pump Inhibitor (PPI) medicines may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines. If you have watery stool, stomach pain, and fever that does not go away, call your doctor immediately.
- People who are taking multiple daily doses of Proton Pump Inhibitor (PPI) medicines for a long period of time may have an increased risk of fractures of the hip, wrist, or spine.
- Low magnesium can happen in some people who take a PPI medicine for at least 3 months. Tell your doctor right away if you experience any of these symptoms: seizures, dizziness, abnormal or fast heartbeat, jitteriness, jerking movements or shaking (tremors), muscle weakness, spasms of the hands and feet, cramps or muscle aches, or spasm of the voice box.
- In adults, the most common side effects with ACIPHEX include pain, sore throat, gas, infection, and constipation.
- In adolescents, the most common side effects with ACIPHEX include headache, diarrhea, nausea, vomiting, and abdominal pain.
- In children 1-11 years of age, the most common side effects with ACIPHEX include abdominal pain, diarrhea and headache.
- Before taking ACIPHEX, tell your doctor if you are taking any of these medicines: atazanavir, digoxin, iron salts, ketoconazole, warfarin, or methotrexate.
For more information ask your doctor or pharmacist or visit www.Aciphex.com. Please see Full Prescribing Information or call Eisai Medical Information at 888-274-2378. To report suspected adverse reactions, call 888-274-2378.
For patient assistance information about this product visit Eisai Reimbursement.com or call 800-226-2072.
Package Insert: Aciphex (rabeprazole sodium).pdf
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